AMMONIA N 13- ammonia n-13 injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

AMMONIA N-13 (UNII: 9OQO0E343Z) (AMMONIA N-13 - UNII:9OQO0E343Z)

Prieinama:

Ionetix Corporation

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. None Pregnancy Category C Animal reproduction studies have not been conducted with Ammonia N 13 Injection. It is also not known whether Ammonia N 13 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ammonia N 13 Injection should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from Ammonia N 13 Injection, use alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-lives of radioactive decay for N 13 isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Ammonia N 13 Injection has been established in pediatric patients based on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinical studies in adults [see Dosage and Administration (2.4)].

Produkto santrauka:

Ammonia N 13 Injection is a clear and colorless solution packaged in 10 mL single dose glass vial containing between 0.8325 GBq to 8.325 GBq (22.5 mCi to 225 mCi) or in a 5 mL single dose syringe containing between 0.555 GBq to 5.55 GBq (15 mCi to 150 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 4 or 6 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of Ammonia. Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Use the solution within 45 minutes of the End of Synthesis (EOS) calibration.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

AMMONIA N 13- AMMONIA N-13 INJECTION
IONETIX CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMMONIA N 13 INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA N
13 INJECTION.
AMMONIA N 13 INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
Ammonia N 13 Injection is a radioactive diagnostic agent for Positron
Emission Tomography (PET)
indicated for diagnostic PET imaging of the myocardium under rest or
pharmacologic stress conditions to
evaluate myocardial perfusion in patients with suspected or existing
coronary artery disease ( 1).
DOSAGE AND ADMINISTRATION
Rest Imaging Study ( 2.1):
Aseptically withdraw Ammonia N 13 Injection from its container and
administer 10-20 mCi (0.368 –
0.736 GBq) as a bolus through a catheter inserted into a large
peripheral vein.
Start imaging 3 minutes after the injection and acquire images for a
total of 10-20 minutes.
Stress Imaging Study ( 2.2):
If a rest imaging study is performed, begin the stress imaging study
40 minutes or more after the first
Ammonia N13 injection to allow sufficient isotope decay.
Administer a pharmacologic stress-inducing drug in accordance with its
labeling.
Aseptically withdraw Ammonia N 13 Injection from its container and
administer 10-20 mCi (0.368 –
0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the
administration of the
pharmacologic stress-inducing drug.
Start imaging 3 minutes after the Ammonia N 13 Injection and acquire
images for a total of 10-20
minutes.
Patient Preparation ( 2.3):
To increase renal clearance of radioactivity and to minimize radiation
dose to the bladder, hydrate the
patient before the procedure and encourage voiding as soon as each
image acquisition is completed
and as often as possible thereafter for at least one hour.
DOSAGE FORMS AND STRENGTHS
Glass vial containing between 0.8325 Gbq to 8.325 Gbq (22.5-225mCi) or
5-mL syringe containing between
0.555 GBq to 5.55 GBq (15 m